Safety of high doses of recombinant human growth hormone

Recombinant human growth hormone (r-hGH) is given as substitution therapy to growth hormone-deficient children at 0.01-0.025 mg/kg/day. Higher doses are used for short stature due to Turner's syndrome and for idiopathic short stature (approximately 0.05 mg/kg/day). For metabolic indications such as AIDS-associated wasting and severe burns, even higher doses are required, up to 0.2 mg/kg/day. Worldwide experience with low and medium doses of r-hGH is well documented. Data on long-term treatment with pharmacological doses of r-hGH are scarce. Serono's clinical program for AIDS-associated wasting provides placebo-controlled data on 355 treated patients. The total experience in clinical trials covers more than 100 person-years of treatment on approximately 600 patients. The most common side effects were tissue turgor complex and musculoskeletal discomfort. Leukopenia was found more frequently in placebo patients. Neoplasm, hyperglycemia, hypertriglyceridemia, carpal tunnel syndrome, pseudotumor cerebri and hypercalcemia were not found to be more significant than with substitution therapy.